Korean J Ophthalmol.  2019 Aug;33(4):343-352. 10.3341/kjo.2018.0116.

Efficacy of Topical Cyclosporine Nanoemulsion 0.05% Compared with Topical Cyclosporine Emulsion 0.05% and Diquafosol 3% in Dry Eye

• Park CH
• Kim MK
• Kim EC
• Kim JY
• Kim TI
• Kim HK
• Song JS
• Yoon KC
• Lee DH
• Lee HK
• Chung TY
• Choi CY
• Kim HS

• KMID: 2454775
• DOI: http://doi.org/10.3341/kjo.2018.0116

Abstract

PURPOSE
To evaluate the efficacy and safety of cyclosporine nanoemulsion 0.05% compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%.
METHODS
This was a multicenter, randomized, evaluator-masked, active control, parallel, phase IV study. A total of 227 patients were randomly allocated to instill cyclosporine nanoemulsion 0.05% (CN) twice daily, cyclosporine emulsion 0.05% (CE) twice daily, or diquafosol sodium 3% (DQ) six times daily. Non-inferiority of CN was analyzed by primary endpoint (cornea and conjunctival staining scores at week 12). The secondary endpoints were scores of corneal staining, conjunctival staining, tear break-up time, Schirmer test, and Ocular Surface Disease Index at weeks 4 and 12.
RESULTS
Primary endpoints showed statistically significant improvements in all groups. Primary endpoints were −6.60 for the CN group, −5.28 for the CE group, and −6.63 for the DQ group (National Eye Institute scale from 0 to 33), verifying the non-inferiority of CN compared to CE (95% confidence interval, −0.15 to 2.80, Δ>−2.88). In intergroup comparison between CN and CE groups, the CN group had significantly more decreased conjunctival staining score at week 12. Intergroup comparison between CN and DQ groups showed consistent statistically significant improvements in TBUT and Schirmer test in the CN group. In the DQ group, TBUT showed late statistically significant improvement at week 12 and Schirmer test showed relatively short-term statistically significant improvement at week 4.
CONCLUSIONS
Cyclosporine nanoemulsion 0.05% was equivalently efficient compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%. In addition, CN showed significant improvements in several parameters for treatment of dry eyes.

Keyword

Cyclosporine; Diquafosol; Dry eye syndromes; Nanotechnology

MeSH Terms

Cyclosporine*
Dry Eye Syndromes
Humans
Nanotechnology
Sodium
Tears
Cyclosporine
Sodium

Figure

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  Fig. 1 Schematic illustration of study design.

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  Fig. 2 Secondary endpoints. (A) Changes in corneal fluorescein staining score from baseline (National Eye Institute [NEI] scale from 0 to 15). *p < 0.05. (B) Changes in conjunctival lissamine green staining score from baseline (NEI scale from 0 to 18). *p < 0.05. (C) Change in tear break-up time (TBUT) from baseline. *p < 0.05. (D) Changes in Schirmer test score from baseline. *p < 0.05. (E) Changes in Ocular Surface Disease Index (OSDI) score from baseline (OSDI score from 0 to 100). *p < 0.05.

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